Canada Unveils Guidance on Production and Marketing of Infant Formula & Human Milk Fortifiers

On March 28, 2023, Health Canada unveiled a series of guidance documents on the production control and marketing approval of infant formula milk powder and human milk fortifiers (HMFs). The guidance is designed to assist stakeholders in the interpretation of policies and regulations, as well as in the preparation of premarket submissions when seeking approval from Health Canada for infant formulas and HMFs. The guidance cover eight aspects:

1. Sales requirements for HMFs 

In Canada, human milk fortifiers (HMFs) are infant foods added to human milk to increase its nutritional value in order to meet the particular requirements of infants who have physical or physiological conditions resulting from diseases, disorders, or abnormal physical states. This document centers on the sale of HMFs, such as sales/purchase channels.

2. Infant formula and HMFs premarket submissions 

In Canada, manufacturers must submit a premarket submission prior to selling or advertising any new infant formula or HMF, or an infant formula or HMF that has undergone a major change. Upon completion of the premarket submission, a letter will be issued for the sale of the product in Canada. This document provides assistance on the preparation of premarket submissions, including the submission process and required information.

Notably, for overseas products intended for release in the Canadian market, relevant post-marketing information provided from the regulators of the exporting country may help to streamline Health Canada's review process.

3. Scientific evidence requirements for nutritional adequacy of preterm infant formula and HMFs

Preterm infant is defined as a baby born alive before the completion of the 37th weeks of pregnancy.

When submitting a premarket application for infant formula, apart from the information on the composition and manufacturing of the infant formula and its packaging and labelling, the applicant is also required to submit evidence to establish that the new or updated infant formula is safe and nutritionally adequate to promote acceptable growth and development in preterm infants. This document provides guidance to manufacturers on the necessary scientific evidence for establishing the nutritional adequacy of a new preterm infant formula and new HMFs, or those that have undergone a major change.

4. Scientific evidence requirements for nutritional adequacy of term infant formula

Healthy term infant means infant delivered between gestational age of 37 to 42 weeks with birth weight of ≥ 2.5 kilograms with no disease.

When submitting a premarket application for infant formula, apart from the information on the composition and manufacturing of the infant formula and its packaging and labelling, the applicant is also required to submit evidence to establish that the new or updated infant formula is safe and nutritionally adequate to promote acceptable growth and development in term infants. This document provides guidance to manufacturers on the necessary scientific evidence for establishing the nutritional adequacy of a new term infant formula or one that has undergone a major change.

5. Growth and tolerance clinical trial protocol for preterm infant formula and HMFs

This document provides guidance on conducting growth and tolerance studies to ensure the infant formulas and HMFs support the end goal of being safe and nutritionally adequate for preterm new-born infants.

6. Growth and tolerance clinical trial protocol for term infant formula and HMFs

This document provides guidance on conducting growth and tolerance studies to ensure the infant formulas and HMFs support the end goal of being safe and nutritionally adequate for healthy term newborn infants.

7. Good manufacturing practices for infant formula

This document establishes general requirements for the effective control of ingredients, formulations, processes, facilities and equipment used for the production of all infant formulas to be sold, distributed or marketed in Canada, regardless of whether the infant formula is manufactured in Canada or in another country. The information in this document can also apply to HMFs.

8. New manufacturing facility requirements for infant formula and HMFs

When submitting a premarket application for infant formula, the dossier shall include the details of the manufacturing process and quality control procedures used throughout processing. This document provides guidance on the information required when an infant formula or HMF is manufactured in a new facility, or an existing facility where it is manufactured for the first time.